Registration Dossier
Registration Dossier
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EC number: 276-974-8 | CAS number: 72901-31-6
Endpoint summary
Administrative data
Description of key information
Additional information
Justification for analog approach of substances and read-across
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests", which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby substances may be considered as an analogue substances provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, the substances listed below are structural similar related secondary fatty amides. In particular, for each specific endpoint the source substance(s) structurally closest to the target substance is chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across.
A detailed justification for analogue approach of chemicals and read-across is provided in the technical dossier (see IUCLID Section 13).
Read-across from (Z)-N-Octadec-9-enylhexadecan-1-amide (oleyl palmitamide, CAS No. 16260-09-6) to 9-Octadecenamide, N-(9Z)-9-octadecen-1-yl-, (9Z) (oleyl oleamide, CAS No. 72901-31-6).
The target substance and the source substance are amides of unsaturated or saturated fatty acids, respectively. The target substance, oleyl oleamide, and the source substance, oleyl palmitamide, are secondary N-alkyl alkylamides produced from a coupling reaction between an appropriate fatty acid and a fatty amine (March, 1992). It should be noted that the original raw materials used for manufacture of the fatty amines are also similar (or the same) fatty acids. For the following endpoints, data from the related substance (oleyl palmitamide) will be used as read-across:
Short term toxicity data for invertebrates and algae are available for (Z)-N-Octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6). The test substance is highly insoluble in water and no effects were observed to aquatic algae and daphnia in the range of water solubility of(Z)-N-Octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6).
The ECOSAR v1.11 Class-specific Estimations (amides) for fish 96h LC50 is 7.04E-8 mg/L. The QSAR output suggests that this chemical may not be soluble enough to measure this predicted effect. If the effect level exceeds the water solubility by 10X, typically no effects at saturation (NES) are reported. In this case, the predicted effect level exceeds the water solubility by 1193X.
Details on the methodology of the ECOSAR QSAR can be located in Section 6.1.3 of the IUCLID.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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